Effects of Bracing on Knee Osteoarthritis (OA)

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: Knee OA Brace

• Registration Number: NCT01886144
• Lead Sponsor: Stony Brook University

Brief Summary

Knee osteoarthritis (OA) is characterized by complaints of knee pain, aching and stiffness that commonly alter the way one will climb stairs and walk reducing an individual's function and the activities they may perform on a day-to-day basis. Providing a person with a knee brace designed for OA can help unload the arthritic part of the knee, thereby reducing pain and lead to improved function. The purpose of this study is to determine if use of the Rebel Reliever knee brace manufactured by Townsend Design can reduce pain and stiffness, improve strength and balance, and enhance functional activities such as stair and level gait, and ultimately lead to increased participation in the community.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-25
• Study Start: 2013-07
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Male or female
• Aged between 35 and 70
• Present with diagnosed unicompartment osteoarthritis of the knee

Exclusion Criteria

• Severe cardiac or pulmonary disease that limits ability to walk.
• Presence of hip, ankle or foot OA or other lower limb pathology that limits ability to walk.
• Bilateral knee OA
• Previous use of an OA knee brace
• Surgical procedure in either leg within the past 6-months
• Anthropometrics that are incongruent with manufacturer's specifications for the Rebel Reliever

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Knee OA	Knee OA Brace	People with knee OA of one knee

Primary Outcome Measures

Name	Time	Method
Change in Knee Injury and Osteoarthritis Score (KOOS)	Baseline, 1 week, 2 week, 2 months, 3 months, 6 months
Change in Adductory knee force during stair climbing	Baseline, 2 weeks, 2 months

Secondary Outcome Measures

Name	Time	Method
Change in Balance	Baseline, 2 weeks, 2 months
Change in 6 Minute Walk Test	Baseline, 2 weeks, 2 months

Trial Locations

Locations (1)

Stony Brook University; Rehabilitation Research and Movement Performance (RRAMP) Laboratory; 🇺🇸 Stony Brook, New York, United States